Actively Recruiting
Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE)
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-12
54
Participants Needed
1
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Infectious endocarditis (IE) and other severe infections are well-known to induce significant changes in the immune response including immune functionality in a considerable number of affected patients. In fact, numerous patients with IE develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/or functional anergy. This was previously referred to as "injury-associated immunosuppression (IAI)" by Pfortmüller et al., published in Intensive Care Medicine Experimental 2017. IAI can be assessed by measurement of cellular (functional) markers. Persistence of IAI is associated with prolonged ICU length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in immunostimulatory (randomized controlled) clinical trials. CytoSorb® treatment is currently used as standard of care in some institutions in surgically treated IE patients. The investigators aim to investigate two accepted treatment protocols and aim to explore whether adsorption with a cytokine adsorption filter can increase immune competence in treated individuals.
CONDITIONS
Official Title
Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for routine cardiac surgery for infectious endocarditis diagnosed by DUKE criteria with antibiotic therapy for 4 days or less
- Provided informed consent
- Age 18 years or older
You will not qualify if you...
- Treated within the last 6 months with immunologically-active biologicals or specific immunomodulatory drugs such as Rituximab
- On chronic high-dose steroid medication exceeding 30 mg prednisone equivalent per day before infectious endocarditis onset
- Receiving extracorporeal membrane oxygenation (ECMO) or any other pre-operative cardiac assist device
- Moribund with a life expectancy less than 14 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dept of Intensive Care Medicine
Bern, Switzerland, 3010
Actively Recruiting
Research Team
J
Joerg C Schefold, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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